PhysioGlove Versus Clinic Electrocardiogram Comparison

• Conditions: Patients With Normal ECG; Patients With Pathological ECG

• Registration Number: NCT01407250
• Lead Sponsor: Meir Medical Center

Brief Summary

Comparison of the quality of the outpatient clinic electrocardiogram performed on patients sent to a cardiology consultation with a standard cable and the PhysioGlove-ES electrocardiograms performed in the cardiology clinic.

Detailed Description

The correct performance of a 12 lead electrocardiogram depends on the correct placement of the electrocardiogram electrodes in internationally agreed upon anatomic locations on the patient's limbs and chest. This process requires specific training and diligence on the part of the electrocardiogram performer. The literature points towards a progressive quality degradation of the electrocardiogram performance probably due to the delegation of it's performance to lesser trained individuals. This study is attempting to ascertain the quality of the electrocardiogram recordings performed in non-specialized out patient clinics.

For this purpose we will compare outpatient electrocardiograms of patients referred to a cardiological consultation with electrocardiogram's acquired using a conventional electrocardiogram cable as well as the PhysioGlove-ES by the well training cardiology clinic personnel.

Study Timeline

• Status Verified: 2011-07
• Study First Submitted: 2011-07-24
• Study First Submitted QC: 2011-07-31
• Last Update Submitted: 2011-07-31
• Study Start: 2011-08
• Study First Posted: 2011-08-02
• Last Update Posted: 2011-08-02
• Primary Completion: 2011-11
• Study Completion: 2012-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

all consenting male and female patients age 18-95 -

Exclusion Criteria

1. All patients using shirt-sizes under small mand over extra-large
2. all patients with severe chest malformations or open wounds or contagious skin infections involving the chest and/or arms -

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of the technical and diagnostic quality of outpatient clinic electrocardiogram with the on-site (cardiology consultation clinic) performed electrocardiograms	Each patient will be tested once while visiting the cardiology consultation clinic. No further patient follow-up is planed. Data collection and evaluation is estimated at 6-9 months from study initiation	The cardiology clinic electrocardiogram will be compared to the out-patient electrocardiogram brought by the patient to the cardiology consultant

Trial Locations

Locations (1)

Clalit- Cardiology consult clinic; 🇮🇱 Natanya, Israel